Development and Production of Parenteral Dosage Forms for Clinical Studies

用于临床研究的肠胃外剂型的开发和生产

• 批准号: 7962442
• 负责人: TIMOTHY SMITH
• 金额: $ 78.4万
• 依托单位: BEN VENUE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-31 至 2013-12-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7962442
• 关键词: Development; Production; Parenteral; Dosage; Forms

The primary objective of this project is to develop and produce pharmaceutically acceptable parenteral dosage forms of promising new agents with activity against cancer. Certain agents selected by the NCI, Division of Cancer Treatment and Diagnosis (DCTD) Cancer Operating Committees will be assigned for development and production as parenteral products (primarily sterile freeze dried products). Batch sizes shall range from small batches (less than 100 units) to intermediate size batches to be used in Phase I and II trials; however, escalation to large batch sizes (1 - 10,000 or more units) for advanced Phase II/III trials is also possi¿ble. The capability to develop and manufacture other pharmaceutical dosage forms (i.e. large volume parenterals, sterile emulsions, liposomes and sterile micro-dispersions) is desirable but not essential. Data obtained from this contract may 1) be used to support IND applications submitted by the National Cancer Institute to the U.S. Food and Drug Administration as well as foreign agen¿cies, 2) be provided to other NCI contractors engaged in large scale dosage form manufacture and analytical evaluation of these dosage forms and 3) be provided to physicians, pharmacists, nurses, and other medical personnel handling these products in a clinical setting.

该项目的主要目标是开发和生产具有抗癌活性的有前景的新型药物的药学上可接受的肠外剂型。由NCI癌症治疗和诊断部门（DCTD）癌症运营委员会选择的某些药物将作为非注射产品（主要是无菌冻干产品）进行开发和生产。批量应从小批量（少于100个单位）到中等批量，用于I期和II期试验；然而，升级到大批量（1 - 10,000个或更多单位）进行高级II/III期试验也是可能的。开发和生产其他药物剂型（即大容量注射剂、无菌乳剂、脂质体和无菌微分散体）的能力是可取的，但不是必需的。